Clinical Trial Examines Diabetes Medications for Heart and Kidney Protection

Clinical Trial Examines Diabetes Medications for Heart and Kidney Protection.

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MedStar Health is participating in a pragmatic trial led by Brigham and Women’s Hospital to understand the heart- and kidney-protective benefits of type 2 diabetes medications. 

 

Diabetes can have a significant long-term impact on the body, increasing the risk of cardiovascular and kidney disease. We’re participating in a unique, pragmatic (real-world) study to help patients and doctors understand which of two classes of diabetes medications offer the best protection against these complications.


Type 2 diabetes means the body doesn’t produce enough insulin and can’t use it properly. This can raise blood sugar levels, potentially damaging organs, and blood vessels over time. While these changes happen subtly, their impact on the heart and kidneys can be life-altering.


Today, more than 40 million people in the U.S., or about 1 in 8 adults, are living with diabetes. About 90-95% of them have type 2 diabetes, which more than doubles the risk for heart disease. Almost 40% of U.S. adults with diagnosed diabetes also have chronic kidney disease


Because the heart, kidneys, and blood vessels are all connected, damage in one area of the body increases the chances of having damage in another. That is why protecting the kidneys and heart is an important part of comprehensive diabetes care.


Two tools to prevent diabetes complications.

Two classes of effective, Food and Drug Administration-approved medications have been shown to lower blood sugar and reduce the risk of heart and kidney disease:

  • SGLT2 inhibitors: Medications such as Jardiance, Farxiga, and Invokana help the kidneys remove excess sugar from the body through the urine. 

  • GLP-1 receptor agonists and GLP-1/GIP receptor agonists: Drugs including Trulicity, Ozempic, Mounjaro, and Rybelsus mimic the GLP-1 hormone and/or GLP-1/GIP hormones to help lower blood sugar and support weight loss.

MedStar Health is participating in a study to compare these medication classes for their specific effects on heart and kidney disease prevention.

How the PRECIDENTD study finds real-world answers.

The study, called Prevention of Cardiovascular and Diabetic Kidney Disease in Type 2 Diabetes (PRECIDENTD), is led by Brigham and Women’s Hospital. Jean Young Park, MD, and I lead the project at MedStar Health. 


In many clinical trials, researchers compare a new medication to a placebo, an identical pill or injection with no effect. In the real world, doctors and patients usually decide between two more active, effective treatments. As a pragmatic study, PRECIDENTD directly compares SGLT2 inhibitors and GLP-1 or GLP-1/GIP receptor agonists.


The study is designed to fit into participants’ lives as simply as possible:

  • Random assignment: A computer randomly assigns patients to one of the two medication classes to help ensure the results are unbiased. 

  • Real-world conditions: Participants continue to see their regular diabetes care provider, and the research team helps fit the trial medication into their treatment plan.

  • Pharmacy convenience: Prescriptions are sent to participants’ usual pharmacy, and they are picked up like any other medication.

Because complications of diabetes can take time to develop, the PRECIDENTD study will follow participants to gather detailed health information through 2029. This gives us time to gather enough data to say which medications perform best over time confidently.


With the PRECIDENTD study, we are working to help more patients and their providers understand and benefit from powerful diabetes medications. By enrolling participants from all walks of life, we are finding answers that can help us provide better, more precise, personalized care for everyone living with type 2 diabetes.


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